The Effect of Probiotics on the Rate of Recovery of Inflammatory Bowel Disease Exacerbation, Endothelial Function, and Markers of Inflammation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by The Baruch Padeh Medical Center, Poriya.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ministry of Health, Israel
Information provided by:
The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT01078935
First received: March 1, 2010
Last updated: August 10, 2011
Last verified: March 2010
  Purpose

Fifty patients will get probiotics (109 bacteria [L. acidophilus, B. bifidum, S. thermophilus, L. rhamnosus, L. casei] in 2 capsules) and half will get placebo (2 capsules that look the same like the probiotic capsules and will contain microcrystalline cellulose, artificial brown color, magnesium strearate, and silica dioxide). The patients and the staff will be blinded to the identity of the study medications.

Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.

Each individual will be studied for changes in biochemical inflammatory and immunological markers and changes in flow medicated diameter that will be measured by the brachial artery method (that is evaluating endothelial function). Every patient will be evaluated for his/her ability to produce endothelial progenitor stem cells (EPCs).


Condition Intervention Phase
Crohn's Disease
Ulcerative Colitis
Dietary Supplement: probiotics
Dietary Supplement: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effect of Probiotics on Bowel Disease

Resource links provided by NLM:


Further study details as provided by The Baruch Padeh Medical Center, Poriya:

Primary Outcome Measures:
  • Truelove and Witts Classification of Ulcerative Colitis [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Crohn's disease activity index (CDAI) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: probiotics
    Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.
    Dietary Supplement: placebo
    Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with ulcerative colitis and crohns' disease

Exclusion Criteria:.

  • notable caveats are that arteries smaller than 2.5 mm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078935

Contacts
Contact: Arnon Blum, DR 972466522688 ablum@poria.health.gov.il

Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Ministry of Health, Israel
  More Information

No publications provided

Responsible Party: Arnon Blum, The baruch pade medical center, Poriya
ClinicalTrials.gov Identifier: NCT01078935     History of Changes
Other Study ID Numbers: Prob-bl.CTIL
Study First Received: March 1, 2010
Last Updated: August 10, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by The Baruch Padeh Medical Center, Poriya:
Crohn's disease activity index
CDAI

Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014